Adjunctive Therapy to Treat Tibial Shaft Fractures (TSF)

This study has been completed.
Sponsor:
Collaborator:
Baxter BioScience
Information provided by (Responsible Party):
Kuros Biosurgery AG
ClinicalTrials.gov Identifier:
NCT00533793
First received: September 20, 2007
Last updated: March 15, 2012
Last verified: March 2012
  Purpose

A phase 2, prospective, randomized, controlled, open-label (dose-blinded), parallel group, international multi-center study. The study will consist of four treatment groups - one control group (SoC) and three I-040202 groups receiving SoC plus 0.133 mg/mL, 0.4 mg/mL or 1.0 mg/mL I-040202.


Condition Intervention Phase
Trauma
Procedure: open fracture reduction
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Randomized, Controlled, Open-labeled (Dose-blinded) Dose Finding Study of the Safety and Efficacy of I-040202 in the Treatment of Patients With Acute Open Tibial Shaft Fractures

Resource links provided by NLM:


Further study details as provided by Kuros Biosurgery AG:

Primary Outcome Measures:
  • Clinical Criteria:weight bearing,red.pain,walking without aid;lack of need for surg. interv. fracture site;Radiogr. crit.:Cortical bridging,disintegration/disappearance fracture lines,absence of signs for complications(infection,malunion) [ Time Frame: short term follow-up: 6 months; long term follow-up: additional 6 months (total duration of 1 year) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Prop. patients healed 3,9,12 mths after T0; prop. time, extent radiogr. union for 2,3,4,5,6,9,12 mths after T0; Eval.:6 and 12 mths; prop./invasiven. sec. interv. due to persistent non-union within 6,12 mths after T0. [ Time Frame: short term follow-up: 6 months; long term follow-up: additional 6 months (1 year) ] [ Designated as safety issue: Yes ]

Enrollment: 201
Study Start Date: April 2007
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: SoC
Standard of Care
Procedure: open fracture reduction
internal fracture fixation: osteosynthesis plates or intra-medullary nails
Active Comparator: SoC plus 0.133 mg/mL Procedure: open fracture reduction
internal fracture fixation: osteosynthesis plates or intra-medullary nails
Active Comparator: SoC plus 0.4 mg/mL Procedure: open fracture reduction
internal fracture fixation: osteosynthesis plates or intra-medullary nails
Active Comparator: SoC plus 1.0 mg/mL Procedure: open fracture reduction
internal fracture fixation: osteosynthesis plates or intra-medullary nails

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Eligible patients must meet all of the following inclusion criteria:

  1. patients with an acute open fracture of the tibial shaft secondary to trauma assessed by medical examination and current radiographs indicated for open fracture reduction and internal fixation using osteosynthesis plates or intra-medullary nails
  2. soft tissue management (if medically warranted, eg. debridement, irrigation, application of antibiotics) performed according to local hospital practice no later than 24h after the trauma
  3. male and female patients >= 18 years
  4. body mass index (BMI) 16-33 (minimum body weight 50 kg, maximum 140 kg)
  5. females of child-bearing potential must be willing to undergo a pregnancy test (urine) prior to treatment start (at screening)
  6. females of child-bearing potential randomized in the intervention group must agree to have acceptable contraception for at least 3 months after receiving the study medication.

    Acceptable contraceptive measures are:

    • Hormonal types of birth control with a failure rate of less than 1% per year (such as implants, injections, combined oral contraceptives, patches or other methods) or copper IUDs or other IUDs with a failure rate of less than 1% per year, AND
    • An additional barrier type of birth control measure (such as condoms, diaphragms, cervical caps, etc.) Sterilized women and abstinent women of child-bearing potential will not be required to take contraceptive measures
  7. willingness and ability to understand, participate and comply with the study requirements
  8. patient be able to give consent personally and sign the Informed Consent Form.

Exclusion criteria:

Patients will be not eligible if they meet one of the following exclusion criteria:

  1. IIIc open fracture according to the Gustilo-Anderson classification
  2. tibial defects requiring bone-grafting (e.g. large segmental defects)
  3. duration from trauma to surgery longer than 14 days
  4. concomitant acute bone injuries and/or major skin or other significant injuries that in the opinion of the investigator would interfere with the tibial shaft fracture healing process
  5. concomitant ipsilateral tibial fractures other than in the diaphyseal region
  6. evidence of immune suppression
  7. suspected or known hypersensitivity to the study medication or components of it
  8. evidence of hypercalcemia
  9. hyperparathyroidism
  10. on treatment and/or planned treatment with products containing PTH (e.g. Forteo)
  11. pregnant or lactating females
  12. participation in another clinical trial within the last 3 months
  13. active or past history of malignant tumor
  14. history or evidence for any hereditary or acquired chronic metabolic bone disease other than primary osteoporosis.
  15. history or evidence for any clinically relevant organ failure or any other relevant medical condition that, in the opinion of the investigator, will relevantly interfere with the assessment of study outcome or will impose hazard to the patient if study therapy will be initiated
  16. known history of allergy to anaesthetics
  17. evidence of moderate or severe renal failure (serum creatinine > 3.0 times ULN, NCI CTC grades 3 and 4)
  18. known history of allergic thrombocytopenia (type II) induced by heparin
  19. inexplicable elevations of alkaline phosphatase or alkaline phosphatase > 5.0 times ULN, NCI CTC grades 3 and 4
  20. prior external beam or implant radiation therapy to the skeleton
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00533793

  Show 49 Study Locations
Sponsors and Collaborators
Kuros Biosurgery AG
Baxter BioScience
Investigators
Study Director: Virginia Jamieson, MD Kuros Biosurgery
  More Information

No publications provided

Responsible Party: Kuros Biosurgery AG
ClinicalTrials.gov Identifier: NCT00533793     History of Changes
Other Study ID Numbers: CS I-040202/01
Study First Received: September 20, 2007
Last Updated: March 15, 2012
Health Authority: Switzerland: Swissmedic
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Czech Republic: State Institute for Drug Control
Hungary: National Institute of Pharmacy
Romania: National Medicines Agency
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Slovakia: State Institute for Drug Control
Slovenia: Agency for Medicinal Products - Ministry of Health
Finland: Finnish Medicines Agency

Keywords provided by Kuros Biosurgery AG:
bone, tibial shaft fracture

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on April 20, 2014